Pharmacodynamics

Tests that compared changes in mineral density in the bone tissue region in people who used the medication, as well as in those who received IV injections of drugs (150 mg), showed no significant differences in the loss of density between the 2- with the above groups after 2 years of therapy.

In the process of the second controlled drug testing, in which adult women participated, drug injections were used in the amount of 150 mg (the treatment duration was up to 5 years). At the same time, there was an average decrease in bone density in the thigh area with the spine (by about 5-6% compared to no significant changes in these values in the control group). The decrease in the observed values of bone density was more pronounced in the interval of the first 2 years of drug use, and in subsequent years the severity decreased. The average indices of density changes in the lumbar region were: -2.86% (1st year), -4.11% (2nd year), -4.89% (3rd year), -4.93 % (4 th year) and -5.38% (5th year). The average reduction in density in the region of the femur, as well as the cervix, were similar to the above values.

After the end of the use of drugs, the density indicators were increased in comparison with the initial figures observed during the post-therapeutic period. With more prolonged therapy, a decrease in the rate of recovery of density indices was usually observed.

Changes in densities in girls aged 12-18 years.

Data from an open, non-randomized drug test for the use of a drug (150 mg at intervals of 12 weeks between procedures-for a 240-week period (or 4.6 years), followed by post-therapeutic control for girls aged 12-18 also found that IM injections of the drug led to a marked decrease in the level of mineral density (compared with the initial values) .In girls who were injected ≥4 injections during a period of 60 weeks, the average reduction rate is tight (application in the interval of 240 weeks, 4.6 years.) For the bone of the thigh and its neck, the average figures for the decrease in density were, respectively, -6.4%, and-5.4% .

Surveys after the completion of therapy showed (based on the average) that the level of density in the lumbar region returned to its initial parameters 1 year after the end of treatment, and the density in the thigh area was completely restored after 3 years. But it is important to clarify that many patients refused to continue to participate in the testing before its completion. As a consequence, the test data are based on a small number of treated girls (71 people 60 weeks after the completion of the course, and only 25 - after 240 weeks).

At the same time, in comparison with the girls using Depo-Provera, an increase in the average density level after 240 weeks-6.4% was observed in an incommensurable group of patients who did not receive the therapy described above, and at the initial stage had different values of bone mass (lower back), 1.7% (femur) and 1.9% (femoral neck).

Pharmacokinetics

The active ingredient of the drug, administered parenterally, is a progestational steroid with a lasting effect. A longer duration of exposure is provided by a slow process of absorption of the substance from the site of injection. After the administration of 150 mg / ml of the drug, its plasma index was 1.7 ± 0.3 nmol / l. After 2 weeks, these values were 6.8 ± 0.8 nmol / l. Initial values of the concentration of drugs were observed at the end of 12 weeks after the procedure. At small dosage sizes, the plasma indices of acetate medroxyprogesterone are considered directly dependent on the used doses of drugs. Cumulation of the substance inside the serum is not observed.

The active component of the drug is excreted with feces or urine. The plasma half-life is approximately 6 weeks (after a single injection). There is information about the presence of at least 11 decay products. All elements are excreted together with urine, some of them in the form of conjugates.

Use of the depot-checks during pregnancy

Depo-Provera should not be given to pregnant women for both therapy and diagnostic procedures.

The doctor is required to perform a patient's examination for pregnancy before injecting the 1st injection.

The active component of the drug with its decay products is able to penetrate into the mother's milk, but there is no information that allows it to be considered dangerous for the baby. Surveys were carried out on children who were exposed to the drug during the lactation period, regarding its effect on their behavior and development prior to puberty. No negative manifestations were noted.

Contraindications

The main contraindications:

the presence of intolerance with respect to the active component of the drug and its auxiliary elements;

use as a contraceptive in the case of presence in the patient of diagnosed or suspected hormone-dependent tumors of malignant type in the genital area or breast;

in the presence of severe hepatic pathologies (or in the presence of them in an anamnesis, when the functional values of the liver are not normalized);

an appointment for monotherapy or for complex treatment with estrogens for women / girls who have bleeding from the uterus of a pathological nature (until the diagnosis is established and the probability of the presence of malignant tumors in the genital area is excluded);

use for elderly patients.

Side effects of the depot-checks

The use of Depo-Provera can lead to the development of such side effects:

the reaction of the auditory organs together with the vestibular apparatus: occasionally the vertigo develops;

manifestations of the gastrointestinal tract: often there is abdominal discomfort or pain. Often there is nausea or flatulence. Occasionally there are disorders of the gastrointestinal tract. Rectal bleeding is noted singly;

infectious or invasive processes: often there is a vaginitis;

metabolic disorders and nutritional disorders: often deterioration or increased appetite. Less frequently observed decrease / increase in weight, as well as fluid retention;

disorders in the work of ODA and connective tissues: often there are pain in the back. Sometimes there are spasms in the muscles, arthralgia, as well as pain in the limbs. Perhaps the development of osteoporosis (this includes osteoporotic-type fractures), swelling in the armpits and weakening of density inside bone tissues;

manifestations from the NA: often there are headaches. Less often there is a giddiness. Sometimes there are migraines, a feeling of sleepiness and cramps. Occasionally, there is paralysis. Possible development of fainting;

reactions of the reproductive organs and mammary glands: often there are pains in the sternum, amenorrhea, bleeding between menstruation, and in addition leukorrhea, pain in the pelvic region and metrorrhagia with hypermenorrhea. Less common are vaginal discharge, dry vaginal mucous membranes, infections in the urogenital tract, changes in breast size, dysmenorrhea and dyspareunia, as well as uterine hyperplasia, PMS and ovarian cyst. Occasionally there are bleeding from the nipples and thickening in the area of the mammary glands. Possible development of galactorrhea, bleeding from the uterus of a pathological nature (strengthened, weakened or irregular), obstructing the lactation process, the appearance of a cyst in the vagina or signs similar to pregnancy, and the inability to restore reproductive activity. There is a possibility of erosion of the uterine neck and the development of prolonged anovulation;

vascular disorders: often there are hot flashes. Occasionally there is varicose, increased blood pressure, pulmonary embolism and thrombophlebitis. Possible development of DVT and thromboembolic disorders;

disorders of the CCC function: occasionally there is a tachycardia;

immune manifestations: sometimes there are reactions of increased sensitivity (for example, anaphylactoid symptoms and anaphylaxis, and also Quincke's edema);

reactions of the hepatobiliary system: sometimes there are pathological indicators of liver enzymes or jaundice. Possible functional hepatic impairment;

manifestations of the subcutaneous layer and dermatological diseases: often there is a rash, as well as alopecia and acne. Sometimes there are dermatitis, swelling, hives and itching, and besides hirsutism, chloasma and ecchymosis. Perhaps the appearance of scleroderma and stretch marks on the skin;

manifestations at the site of injection and systemic disorders: often there are reactions at the site of drug administration (among which abscess and pain), as well as paresthesia, increased fatigue and asthenia. Sometimes fever develops or pain in the sternum. Occasionally there is dysphonia, a thirst and paralysis. Paralysis is possible in the area of the facial nerves;

data from laboratory tests: sometimes there are abnormalities in the swabs taken from the uterine neck. Occasionally, glucose tolerance decreases;

mental disorders: often marked by a feeling of nervousness, irritability or emotional disturbance and changes in mood, and in addition to depression, insomnia, anorgasmia and decreased libido. Sometimes there is a feeling of anxiety;

diseases of lymph and systemic blood flow: anemia is occasionally observed. Possible development of blood dyscrasia;

response of respiratory organs and mediastinum with the breastbone: sometimes marked dyspnea.

Dosing and administration

Before performing the injection, it must be ensured that the used dose of the suspension has a completely uniform consistency. To do this, the bottle of medicine is shaken carefully before the procedure.

The drug is administered in / m, deep. It is required to make sure that the injection is performed precisely in the area of muscle tissue (it is recommended to use the gluteus muscle, although variants with other muscles are also possible, for example, deltoid).

Before performing the procedure, the injection site is cleaned using standard techniques.

The 1st injection is 150 mg of the drug. To ensure proper contraceptive effect for the period of the first cycle of use, the injection is performed in the first 5 days of the standard menstrual cycle. When performing the procedure in compliance with this instruction, no auxiliary contraceptive measures will be required.

In the postnatal period: in order to increase the confidence that the treating person is not pregnant at the time of the first injection, it is required to undergo the procedure during the 5 days after delivery (with the amendment that the mother does not feed the baby with breast milk).

There is information that shows that women who started to inject Depo-Provera immediately after birth may develop severe prolonged bleeding. As a consequence, in this period of time, the drug should be used cautiously. Patients who decide to use the medication immediately after childbirth or after an abortion should be informed about the possible risks of such a decision. In addition, it should be indicated that in non-breast-feeding mothers, ovulation can be observed already during the 4th week after the birth process.

Breastfeeding mothers can do the first injection at least 6 weeks after the birth of the child - during this period the infant's enzymatic system is developed more fully. Further procedures are performed at intervals of 12 weeks.

Subsequent dosages: it is necessary to administer the medication at 12-week intervals, but when injections are performed no more than 5 days after the specified time, auxiliary contraceptive measures are not required (eg, barrier).

Affiliates of men who received a vasectomy may require a second IM injection (150 mg) 12 weeks after the first. This is required for a small number of women - those whose partners the number of active spermatozoa has not decreased to zero.

If, for any reason, the interval from the moment of the previous procedure exceeds 89 days (12 weeks + 5 days), before the next introduction of the drug, you must first exclude pregnancy. Further, the woman will need to use additional contraceptive methods (barrier) during the 14 days after the introduction of a new dose of the drug.

When switching from other contraceptive drugs.

The medication is used in such a way that the contraceptive effect is continuous. Therefore, it is necessary to take into account the mechanisms of the effect of other drugs (for example, women switching from oral contraception, it is required to enter the 1st dose of Depo-Provera in the period of 7 days after receiving the last pill).

Interactions with other drugs

When combined with aminoglutethimide, a significant inhibition of the bioavailability of the Depo-Provera drug is possible.

Storage conditions

Suspension is required in a place inaccessible to the child. Do not freeze. Temperature values are a maximum of 25 ° C.

Shelf life

Depo-Provera can be used in the period of 5 years from the date of release of the medicine.

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Attention!

To simplify the perception of information, this instruction for use of the drug "Depot-checker" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.

Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.

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